Wesper Lab Home Test for Sleep Apnea in Children

Overseen By Amir Reuveny, Ph.D

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Tatch Inc.

Disqualifiers: Age, Pregnancy, Health condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 night

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new home sleep test device called Wesper Lab to determine if it can accurately diagnose sleep apnea in children, similar to the traditional overnight hospital test. It targets children and young adults aged 2 to 21 who are already scheduled for an overnight sleep study. Participants will wear the Wesper Lab device and a pulse oximeter during their regular sleep test. Researchers aim to determine if Wesper Lab provides results comparable to the hospital test in detecting sleep apnea and its severity. As an unphased trial, this study allows participants to contribute to research that could make diagnosing sleep apnea more convenient and accessible for children.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Wesper Lab device is safe for use in children?

Research shows that the Wesper Lab device, a wireless home sleep test, is safe to use. Studies have not identified any serious safety issues with the device. Previous research found that the Wesper Lab performs well compared to the traditional sleep study method, polysomnography (PSG), with no unwanted effects linked to its use. The device is also FDA-cleared, indicating it has been reviewed for safety in diagnosing sleep apnea. This suggests ease of use. Participants in the study will wear the device at home, offering a convenient and non-invasive option for testing sleep apnea. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard in-lab polysomnography (PSG) tests for diagnosing sleep apnea, the Wesper Lab device offers a convenient home testing option for children. This device is unique because it allows kids to undergo sleep studies in the comfort of their own homes, which can be less intimidating and more conducive to a natural sleep environment. Researchers are excited about Wesper Lab because it simplifies the diagnostic process and could make it easier to identify sleep apnea in children, potentially leading to quicker and more comfortable diagnoses.

What evidence suggests that the Wesper Lab device is effective for diagnosing sleep apnea in children?

Research has shown that home sleep apnea tests like the Wesper Lab, which participants in this trial will use, accurately diagnose obstructive sleep apnea (OSA) in children. Studies have found these tests excel at identifying moderate-to-severe OSA cases. Although they may not detect mild cases as effectively, they work well for more serious conditions. The Wesper Lab device uses wireless technology and has provided results similar to an overnight sleep study, known as a polysomnography (PSG) test, the best method for diagnosing sleep apnea. This suggests that Wesper Lab could reliably diagnose sleep apnea at home, simplifying testing for children and their families. ^{1 6 7 8 9}

Who Is on the Research Team?

German P Digoy, M.D.

Principal Investigator

Associate Professor of Otolaryngology, Oklahoma State University Center for Health Sciences

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 2 to 21 who are already scheduled for a standard sleep study (PSG) to check for sleep apnea. Participants will use the Wesper Lab home test at the same time as their regular PSG.

Inclusion Criteria

My doctor referred me for an overnight sleep test to check for sleep apnea.

I can sign the consent form myself, or if under 18, my guardian can.

I am willing to wear sleep study devices for one night.

Exclusion Criteria

I am under 2 years old.

I am over 21 years old.

I am a female aged 12 or older and have a positive pregnancy test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo an overnight polysomnography (PSG) while wearing Wesper Lab sensors and a pulse oximeter

1 night

1 visit (in-person)

Follow-up

A follow-up communication is made to assess any adverse events and collect additional data

5 days

1 communication (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Wesper Lab

Trial Overview The study tests how well the Wesper Lab, a wireless home sleep test device, measures sleep apnea compared to traditional overnight polysomnography. It checks if both methods agree on the severity of sleep apnea in participants.

How Is the Trial Designed?

Group I: Medical Device: Wesper Lab (Single Arm) Experimental Treatment 1 Intervention

Participants already undergoing a prescribed polysomnography (PSG) sleep study for the diagnosis of sleep apnea will be asked to simultaneously wear Wesper Lab, a home sleep test device.

Who Is Running the Clinical Trial?

Tatch Inc.

Lead Sponsor

Trials

1

Recruited

150+

Wesper Inc

Lead Sponsor

Trials

1

Recruited

150+

Wasper Inc

Lead Sponsor

Trials

1

Recruited

150+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07095413

Assessing the Performance of Wesper Lab for Obstructive ... The goal of this clinical trial is to evaluate the effectiveness of the Wesper Lab home sleep apnea test as a tool to aid in the diagnosis ...

2. clinconnect.io clinconnect.io/trials/NCT06218186

Assessing the Performance of Wesper Lab for Sleep Apnea This clinical trial is studying a new home sleep test called Wesper Lab, which is designed to help diagnose sleep apnea in children and young adults aged 2 to ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40123540/

Accuracy and acceptability of home sleep apnea testing ... Conclusions: HSAT with EEG was accurate compared to polysomnography for the diagnosis of pediatric OSA. Electroencephalography may improve the ...

4. aasm.org aasm.org/advancements-in-home-sleep-apnea-tests-bridging-convenience-and-clinical-effectiveness/

Advancements in home sleep apnea tests They exhibit strong sensitivity for diagnosing moderate-to-severe OSA, though their sensitivity is lower in mild and mild-to-moderate cases.

5. ctv.veeva.com ctv.veeva.com/study/assessing-the-performance-of-wesper-lab-for-sleep-apnea-diagnosis-in-pediatric-populations

Assessing the Performance of Wesper Lab for Sleep Apnea ... This is a single center, single-arm, quantitative study evaluating the effectiveness of the Wesper Lab, previously known as TatchSleep Pro, ...

6. wesper.co wesper.co/

Wesper - Better Sleep Starts Here Experience PSG-level sleep testing—without wires, belts, or labs. Wesper is FDA-cleared, 95% correlated to in-lab studies, and delivers results in under 20 ...

7. aasm.org aasm.org/novel-devices-applications-diagnosing-obstructive-sleep-apnea/

Novel devices and applications for diagnosing obstructive ... This article is intended to help readers become more informed about newer obstructive sleep apnea diagnostic devices and their underlying novel technologies.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10476032/

Evaluation of a novel device to assess obstructive sleep ... The Wesper device compares favorably with gold-standard polysomnography. Given the lack of safety concerns, we advocate for further study regarding its utility ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352721822001887

A novel technique for measuring airflow using a wireless ... This study aimed to evaluate a new set of wireless patches for the detection of OSA as compared to polysomnography (PSG) respiratory signals.